Self-assembling suture anchor assembly, surgical kit, and surgical repair method

ABSTRACT

A suture anchor assembly includes a main suture strand, a plurality of suture arms, and a plurality of suture anchor elements connected to the main suture strand by a suture arm. The suture anchor elements are configured to rest against a cortex of a bone to provide an anchor when they are in a deployed configuration. The suture anchor assemblies can be employed in place of or in addition to traditional suture anchors. The assemblies, kits, and methods described herein can be utilized in a variety of procedures and locations in the body where anchoring a graft or tissue adjacent a bone is desired, including, for example, rotator cuff repair and ligament (e.g., the anterior cruciate ligament or ACL) reconstruction and/or repair.

The present application is a continuation of U.S. patent applicationSer. No. 16/374,377 entitled “Self-Assembling Suture Anchor Assembly,Surgical Kit, and Surgical Repair Method” filed Apr. 3, 2019, which is adivisional of U.S. patent application Ser. No. 14/037,735 entitled“Self-Assembling Suture Anchor Assembly, Surgical Kit, and SurgicalRepair Method” filed Sep. 26, 2013, which are hereby incorporated byreference in their entireties.

FIELD

The present disclosure relates generally to surgical procedures, andmore particularly to suture anchor assemblies, surgical kits, andsurgical repair methods.

BACKGROUND

The complete or partial detachment of ligaments, tendons or other softtissues from their associated bones within the body occurs relativelyfrequently. For example, the rotator cuff, a group of four muscles thatwrap around the shoulder joint to attach the upper arm to the shoulderblade, in part allows the shoulder to move and turn through a widerrange than any other joint in the body. Unfortunately, tears of therotator cuff are common, making many routine activities difficult andpainful. Similarly, cruciate ligaments of the knee, e.g., the anteriorcruciate ligament, are often completely detached or partially detachedfrom the femur or other associated bone. These types of injuriesgenerally result from excessive stresses being applied to the softtissues. For example, a tissue detaching injury may occur as the resultof a fall, overexertion during a work-related activity, during thecourse of an athletic event, and/or in association with other situationsor physical activities.

A number of surgical techniques exist for reattaching detached tissuesand/or completely replacing severely damaged tissues. One such techniqueinvolves reattachment of detached tissue using traditional attachmentdevices such as metal staples, sutures over buttons, cancellous bonescrews, and/or other anchor devices. These types of traditionalattachment techniques and devices may also be used to attach tendon orligament substitutes to the desired bone or bones. Traditional anchorsoften rely on the quality of the cortical or cancellous bone in order toobtain sufficient purchase. However, traditional anchors rely on strongand healthy cortical and cancellous bone to achieve sufficient purchase.As a result of certain diseases or as the age of a patient increases,bone mineral density often decreases and can compromise bone strength.This can provide a challenge when using traditional anchors in suchbones.

Accordingly, there is a need for improved suture anchor assemblies,surgical kits, and surgical repair methods.

SUMMARY

Described herein are suture anchor assemblies, surgical kits, andmethods of affixing soft tissue to bone using such suture anchorassemblies. The suture anchor assemblies described herein areparticularly useful for soft tissue fixation when bone quality isinsufficient for traditional suture anchors.

In some embodiments, the suture anchor assembly can include a mainsuture strand and a plurality of suture arms, each having at least afirst end attached to the main suture strand. The suture anchor assemblycan further include a plurality of suture anchor elements, eachconnected to one of the suture arms. Additionally, the suture anchorassembly can have a delivery configuration in which each suture elementis substantially aligned along a central axis and able to pass throughan opening in bone and a deployed configuration in which the sutureanchor elements are oriented in a coplanar manner substantially parallelto a bone surface and unable to pass through the opening in bone.

Additionally, surgical repair methods are disclosed. For example, asurgical repair method can include forming a cavity within bone, thecavity having a cavity diameter. The method can include delivering intothe cavity a self-assembling suture anchor assembly in a deliveryconfiguration. The suture anchor assembly can have a main suture strandand a plurality of suture elements each connected to the main suturestrand by a suture arm. The method can further include deploying thesuture anchor assembly by tensioning the main suture strand such thatthe suture elements are rearranged into a deployed configuration. In thedeployed configuration the suture anchor elements are oriented in acoplanar manner substantially parallel to the bone surface and unable topass through the cavity. Furthermore, the method can include securing agraft or soft tissue connected to the suture anchor assembly to bone.

Surgical kits containing suture anchor assemblies are also disclosed.For example, a surgical kit for repairing tendon or ligament can includea suture anchor assembly and an inserter tool. The suture anchorassembly can include a main suture strand, a plurality of suture arms,each having at least a first end attached to the main suture strand, anda plurality of suture anchor elements, each connected to one of thesuture arms, wherein the suture anchor assembly has a deliveryconfiguration in which each suture element is substantially alignedalong a central axis and able to pass through an opening in bone and adeployed configuration in which the suture anchor elements are orientedin a coplanar manner substantially parallel to a bone surface and unableto pass through the opening in bone. The inserter tool can be configuredto house the suture anchor assembly and to selectively maintain thesuture anchor assembly in the delivery configuration until deployment.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a cross-sectional view of an embodiment of a suture anchorassembly in a deployed configuration;

FIG. 2A is a cross-sectional view of an embodiment of a suture arm and asuture anchor element;

FIG. 2B is a cross-sectional view of an embodiment of a suture anchorelement;

FIG. 3 is a schematic view of an embodiment of a suture anchor assemblyin a deployed configuration;

FIG. 4 is a cross-sectional view of an embodiment of a suture anchorelement;

FIG. 5 is a partial top view of the suture anchor assembly of FIG. 1 ina deployed configuration;

FIG. 6 is a cross-sectional view of an embodiment of an inserter toolwith a suture anchor assembly disposed therein in a deliveryconfiguration;

FIG. 7 is a side view of an embodiment of a suture anchor assembly foruse in a rotator cuff repair application;

FIGS. 8A-8C sequentially illustrate an embodiment of a suture anchorassembly in an anterior cruciate ligament reconstruction application.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Further, in the present disclosure, like-numbered components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-numbered component isnot necessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. Sizes and shapes ofthe systems and devices, and the components thereof, can depend at leaston the anatomy of the subject in which the systems and devices will beused, the size and shape of components with which the systems anddevices will be used, and the methods and procedures in which thesystems and devices will be used.

Described herein are suture anchor assemblies, surgical kits, andmethods of deploying suture anchor assemblies. In general, suture anchorassemblies described herein include a main suture strand, a plurality ofsuture arms, and a plurality of suture anchor elements that areconfigured to rest against a cortex of a bone to provide an anchor whenthey are in a deployed configuration. The suture anchor assembliesdescribed herein can be employed in place of or in addition totraditional suture anchors, such as buttons, pins, or screws. Theassemblies, kits, and methods described herein can be utilized in avariety of procedures and locations in the body where anchoring a graftor tissue adjacent a bone is desired. Numerous procedures in which thesuture anchor assemblies described herein can find applicability arewell known. Non-limiting exemplary procedures include securing acruciate ligament (e.g., the anterior cruciate ligament or ACL) graftwithin a bone tunnel in a patient's femur and rotator cuff repair.

FIG. 1 depicts an embodiment of a suture anchor assembly 10 deployedadjacent a bone 12 to secure soft tissue or a graft (not shown) to bone.The suture anchor assembly 10 can include a main suture strand 14 havinga proximal end 16 and a distal end 18 that is configured to extendthrough an opening 20 in the bone 12. The suture anchor assembly 10 caninclude a plurality of suture arms 22 with each extending from the mainsuture strand 14 to one or more of a plurality of suture anchor elements24. The suture assembly 10 can be configured to have multipleconfigurations. For example, and as discussed below, the suture assemblycan be selectively movable between a delivery configuration and adeployed configuration. In the delivery configuration the suture anchorelements are in an aligned orientation, which allows them to be passedthrough the opening 20 in bone 12. In the deployed configuration,illustrated in FIG. 1, typically with the aid of a tensile force appliedto main suture strand 14, the suture anchor elements are arranged in acoplanar manner substantially parallel to a surface of bone 12 such thatthe collective suture anchor element arrangement is unable to passthrough opening 20. As such, the suture anchor assembly is able tosecure soft tissue to bone even when the strength or integrity of boneis compromised and not well suited to the use of traditional sutureanchors. In some embodiments, the suture anchor assembly can furtherinclude a locking mechanism (not shown) and various other suture strandsfor use in delivery and deployment of the suture anchor assembly (notshown).

As mentioned, the main suture strand 14 can have a proximal end 16 and adistal end 18. The proximal end of the main suture strand 14 can beconfigured to be attached to a ligament or tendon graft or to a detachedtendon or ligament or replacement tendon or ligament (not shown), thussecuring the graft or soft tissue element adjacent to the bone 12, aswill be discussed below. The distal end 18 of the main suture strand 14can be configured to extend through the opening 20 in the bone 12. Thedistal end 18 can also be configured to allow the suture arms 22 to beattached to the main suture strand 14. For example, the distal end 18can include a loop or surface feature to tie each suture arm 22 to themain suture strand 14. Alternatively, the distal end 18 of the mainsuture strand can be configured to have the suture arms 22 integrallyformed thereon, for instance by welding, adhering, or otherwise securingthe suture arms 22 thereto. In one embodiment, the main suture strand 14can be formed of a braided suture having a number of filaments (e.g.,three). At the distal end 18 of the braided main suture strand, each ofthe filaments can be separated to form the applicable number of suturearms 22.

The main suture strand 14 can be dimensioned so as to allow sufficientworking material for a surgeon, for example by being pliable and longenough to attach the main suture strand 14 to soft tissue or to a graft.The main suture strand 14 can be any length suitable for the variouspurposes described herein, for example in the range of about 35 cm and137 cm, and more particularly about 86 cm. The main strand 14 can be anythickness suitable for the various purposes described herein, forexample in the range of about #5-0 and #5 as defined by the UnitedStates Pharmocopeia (“USP”) size designation. More particularly, themain strand 14 can have a thickness of about #2 USP size designation.The main suture strand 14 can be formed of any known suture material,including resorbable, non-resorbable, and/or combinations thereof.Exemplary main suture strand materials include for example, catgut,polyglycolide, and polydioxanone, such as EthiBond® available fromEthicon, Inc. and ORTHOCORD® High Strength Orthopaedic Suture availablefrom DePuy Mitek, Inc. Moreover, the main suture strand 14 can be amonofilament or braided.

As shown in FIGS. 1 and 2A, the suture arms 22 can have a first end 28and a second end 30. The first end 28 can be connected to the mainsuture strand 14 at any desired location, for example at a distal end 18of the main suture strand 14 or at a central portion of the main strand14, in a variety of ways, as discussed above. The suture arms 22 can befixedly attached to the main suture strand 14 or can be attached in amanner so as to allow the suture arms 22 to translate along a length ofthe main suture strand 14. The first end 28 of the suture arms 22 canalternatively include a feature, such as a loop, configured to connectthe suture arm 22 to the main suture strand 14. As shown in FIG. 1, allof the suture arms 22 can be connected at a single location on the mainsuture strand 14. In this embodiment, the suture arms 22 are all ofequal length and thus each suture arm 22 will apply approximately thesame force to the corresponding suture anchor elements 24 when a load isapplied to the main suture strand 14. Alternatively, the suture arms canbe attached to the main suture strand 14 at varying locations. Forexample, each suture arm can have a different length and be attached ata location on the main suture strand that is offset by a length that isnominally equivalent to the difference in length between the suturearms. The shortest suture arm can be attached at the most distallocation on the main suture strand and the longest suture arm can beattached the most proximal location on the main suture strand.Importantly, in this varied configuration, the suture arms 22 stillapply approximately the same force to each suture anchor element when aload is applied to the main suture strand.

As will be described in more detail below, the suture arms 22 can be sodimensioned as to allow the suture anchor elements 24 to self-assemblein a substantially coplanar manner adjacent a surface 26 of the bone 12,as shown in FIGS. 1 and 3, when tension is applied thereto. In someembodiments, each suture arm 22 can be capable of withstanding an equalportion of the tension applied to the main suture strand 14. Forexample, in FIG. 1, each suture arm 22 can be capable of supportingapproximately one-third of the tension applied to the main suture strand14. To achieve this, the suture arms can be any thickness suitable fortensioning, for example in the range of about #5-0 and #5 USP sizedesignations, and more particularly about #0. Additionally, the suturearms 22 can be any length suitable to allow proper tensioning of thesuture anchor elements 24 as described herein, for example in the rangeof about 3 mm and 20 mm, and more particularly about 7 mm. The suturearms 22 can be formed of any known suture material, includingresorbable, non-resorbable, and/or combinations thereof. Exemplarysuture arm materials include for example, catgut, polyglycolide, andpolydioxanone, such as EthiBond® available from Ethicon, Inc. andORTHOCORD® High Strength Orthopaedic Suture available from DePuy Mitek,Inc. Moreover, the suture arms 22 can be a monofilament or braided.

The second end 30 of each of the suture arms 22 can be connected to asuture anchor element 24 in any manner suitable to enable secureassembly and to allow a load applied to the suture arm 22 to betransferred to the suture anchor elements 24. For example, as shown inFIG. 2A, the second end 30 can pass through a bore 34 in the sutureanchor element 24 and another feature, such as a knot or a ball end 32,can be utilized to ensure that the suture anchor element 24 does notslide off of the suture arm 22. In another embodiment, as shown in FIG.2B, the suture anchor element 24″ includes a feature that enables thesuture arm to be attached thereto. For example, the suture anchorelement 24″ can have an opening (e.g., a split along a radial plane ofthe suture anchor element) such that there is a gap G between a firstand second portion 40, 42 of the suture anchor element 24″. The gap oropening can be configured to receive a suture arm, and the suture anchorelement can be configured to be deformable so that the suture anchorelement can be secured to the suture arm. Although FIG. 2B illustrates awedge-shaped gap G, one skilled in the art will appreciate that the gapG can be of virtually any shape or size.

Alternatively, as depicted in FIG. 3, the second end 30 can be attachedor connected to a feature 36 on an end of the suture anchor element 24′.For example, the second end 30 can be attached directly to the feature36, which can be virtually any feature that allows for the attachment ofthe suture arm (e.g., a thru-hole or cleat-like projection). The suturearm can be attached by any suitable means, such as those describedabove.

The suture anchor assembly can have a plurality of suture anchorelements 24, and therefore can have a plurality of suture arms 22. Forexample, a suture anchor assembly 10 should have more than one sutureanchor element 24, but can have any number of suture anchor elements 24.For example, between 2 and 5 suture anchor elements will allow forsufficient tensioning between the suture anchor elements to prevent anyone individual element from entering the opening formed through theadjacent bone, thus providing secure attachment of soft tissue. As shownin FIG. 1, the suture anchor assembly 10 has 3 suture anchor elements24.

The suture anchor elements can have any desired geometric shape, andeach element of an assembly can be of the same or different shape. Forexample, FIGS. 1 and 2 depict a substantially spherical suture anchorelements 24. The suture anchor elements 24 can be dimensioned such thatthe outer diameter OD of the element 24 is smaller than the diameter ofthe opening 20 in the bone 12 such that the suture anchor element can bedeployed through the opening 20. But, the diameter of the suture anchorelements 24 should be large enough that a plurality of the elements 24,when tensioned so as to be adjacent to one another in a deployed sutureanchor element assembly, will not pass through the opening 20 oncedeployed. In some embodiments the plurality of suture anchor elements 24have substantially equivalent outer diameters, but in other embodimentsthe outer diameters of the suture anchor elements 24 can vary. Oneskilled in the art will appreciate that the size of the suture anchorelements will depend on a number of factors, including the intendedapplication. However, in one embodiment the suture anchor elements canhave an outer diameter OD in a range of about 1 mm to 10 mm, and moreparticularly about 3 mm.

In other embodiments, the suture anchor elements can have non-sphericalgeometries that fit together in a specific way when in the deployedconfiguration. For example, FIG. 3 depicts a substantially conicalsuture anchor element 24′. The substantially conical suture anchor canhave a pointed proximal end 24′p and a substantially spherical distalend 24′d, such that the substantially conical suture element 24′ has ashape comprising a right circular cone attached to a hemisphere ofidentical diameter. In this embodiment, the suture anchor elements 24′can be dimensioned such that the outer diameter OD of the sphericaldistal end 24′d is smaller than the diameter of the opening 20 in thebone 12 such that the suture anchor element can be deployed through theopening 20. But, the diameter of the suture anchor elements 24′ shouldbe large enough that a plurality of the elements 24′, when tensioned soas to be adjacent to one another, will not pass through the opening 20once deployed. Furthermore, as shown, the proximal end 24′p can bedimensioned such that when aligned in the deployed configuration,portions of the proximal end 24′p can extend into the opening 20.Alternatively, it will be appreciated that the proximal end can be thelarger dimensioned end—that is, essentially reversing the orientation ofthe suture anchor element 24′ shown in FIG. 3.

Additionally, the suture anchor elements can have a substantially smoothsurface, or they can have a variety of surface features formed thereon.In some embodiments, regular indentations and protuberances can beformed on the suture anchor elements to aid in self-assembly of thesuture anchor elements when moving from the delivery configuration tothe deployed configuration, as will be discussed below. FIG. 4 depictsan embodiment of a suture anchor element 24 having one or moreinvaginations or grooves 38 formed thereon. The invaginations 38 can beconfigured to allow a suture strand to be wound around the anchorelement 24. The invaginations 38 can, for example, be configured to havean insertion suture wrapped and/or looped around the suture anchorelement 24, such as shown in FIGS. 8A and 8C. Suture management canoptionally be used to prevent tangling in any of the suture arms 22 andmain suture strand 14.

The suture anchor elements can be formed of any known biocompatiblematerial, for example bone, metals, such as stainless steel and/ortitanium alloys, and polymers, such as polyether ether ketone (PEEK),poly(lactic-co-glycolic acid) (PLGA), and polytetrafluoroethylene(PTFE), and/or ceramics. In some embodiments, materials that promotehealing, such as tricalcium phosphate (TCP) or any other osteoconductiveceramic or polymer, can be used. In some embodiments the anchor can beformed of a material that will completely turn to bone as it heals.Exemplary materials can include Biocryl Rapide® available from DePuySynthes Products, LLC.

As is mentioned above, the suture assembly 10 can be manipulated betweena delivery configuration and a deployed configuration. For example, inan embodiment of the delivery configuration, each suture element 24 canbe substantially aligned along a central axis and able to pass throughan opening in bone, such as opening 20 shown in FIG. 1.

FIGS. 1, 3, and 5 show the suture anchor assembly in a deployedconfiguration. In an embodiment of the deployed configuration, thesuture anchor elements 24 can be oriented in a coplanar mannersubstantially parallel to a bone surface, such as surface 26 in FIGS. 1and 3, and unable to pass through the opening in bone. The sutureassembly 10 can be self-assembling, for example by tensioning the mainsuture strand, the suture elements can be rearranged into a deployedconfiguration in which the suture anchor elements separate and areoriented in a coplanar manner substantially parallel to the bone surfaceand unable to pass through the cavity. To maintain the suture anchorassembly in the deployed configuration, the suture arms 22 can bemaintained at a substantially equal tension. By maintaining each suturearm 22 at a substantially equal tension, the suture anchor elements 24will separate and self-assemble into a coplanar configuration adjacentthe opening 20 that the suture anchor elements 24 were deliveredthrough, as shown in FIG. 5. Upon deployment in this coplanararrangement, as shown in FIG. 5, the suture anchor elements 24 form asuture anchor element assembly that cannot pass through the opening 20.That is, as any individual suture anchor element 24 is tensioned againstany other individual anchor element, the assembly blocks the openingfrom any individual anchor element 24.

As noted above, in the deployed configuration, it is desirable to haveequal or near-equal tension on the individual suture anchor elements 24so that no single suture anchor element can re-enter the opening andthus cause the fixation to fail. A technique of ensuring secure fixationis to simply have all of the suture anchor elements 24 spacedequidistant from the main suture strand 14. This can be accomplished byhaving the length of each of the plurality of suture arms 22 besubstantially equal. Another technique for achieving a similar,iso-tension state is to utilize a locking device (not shown) able toslide down the main suture strand 14 and onto the suture arms 22following deployment of the suture anchor elements 24. Such a lockingdevice can be useful in cases where the suture arms are not of the samelength and/or are subject to un-equal tension. A suitable lockingdevice, which can be any suitable shape, can be fixed upon actuation ata specific point and prevent slippage of the suture arms. One example ofa locking mechanism a ring-like mechanism than can be deformed to itsactuated state. In such an embodiment, the ring can be deformed oractuated by a specific instrument to lock on the suture strand in anydesired location.

In use and following accepted surgical procedures, involving either openor minimally invasive surgery, an opening or cavity in a bone can beformed prior to delivering a suture anchor assembly. For example, apractitioner can use an awl, drill, and/or an inflatable balloon tocreate an opening 20 that has a cavity diameter that is larger than thediameter of an individual suture anchor element 24. In one embodiment,the cavity diameter can be approximately three times larger than theouter diameter OD of an individual suture anchor element 24. The opening20 can be formed such that the suture anchor elements 24 will rest on asuperficial surface of the cortex, or alternatively on a deep surface ofthe cortex.

After formation of the opening in the bone, the suture anchor assemblycan be delivered into the opening. In use, the suture anchor assembly ismaintained in a delivery configuration while being delivered into theopening, as described above. The suture anchor assembly can be deliveredinto the opening in any manner that maintains the assembly in a deliveryconfiguration. For example, a flexible sleeve can be included tomaintain the suture anchor elements in a generally linear alignment.Alternatively, the suture anchor assembly can be delivered to theopening in the bone with an inserter tool. FIG. 6 depicts an embodimentof an inserter tool 100 having a proximal end 100 p and a distal end 100d. The inserter tool 100 can include a hollow tubular member 112 that isconfigured to house the suture anchor assembly 110 and maintain thesuture anchor assembly 110 in a delivery configuration. The insertertool 100 can have a lumen extending from the distal end 100 d to theproximal end 100 p to allow portions of the suture anchor assembly 110,such as the main suture strand (not shown), to extend proximally throughthe inserter tool. The inserter tool 100 can also include a plunger 114,or a similar element, to selectively deploy the suture anchor assembly110. In use, the plunger 114 can be translated distally through thehollow tubular member 112 to push the suture anchor assembly 110 out ofan opening in the distal end 100 d. When the suture anchor assembly 110exits the inserter tool 100, the suture anchor assembly 110 is free toself-assemble to the deployed configuration. The inserter tool 100 canoptionally include an indicator marking on an exterior surface of theinserter tool 100 so as to indicate when the suture anchor assembly 110has been placed deeply enough through the opening in the bone totranslate the plunger distally and deploy the suture anchor assembly110. Once the suture anchor assembly 110 is deployed from the insertertool 100, the main suture strand can be tensioned causing the sutureanchor assembly 110 to self-assemble in the manner described above.

As noted above, the suture anchor assembly described herein isapplicable to a variety of surgical procedures requiring soft tissueand/or graft attachment or reattachment. Two exemplary applications aredescribed below. One skilled in the art will appreciate the generalsurgical technique applicable to the procedure. Thus, the descriptionsbelow emphasize differences in technique occasioned by the use of thesuture anchor assembly described herein. Portions of the technique notaffected by the suture anchor assembly described herein will not bedescribed.

Rotator Cuff Repair

For rotator cuff repair, an inserter tool, much like the one describedin FIG. 6, can be used with the suture anchor assembly 10 depicted inFIGS. 1-5, however, a modified main suture strand 14′, as seen in FIG.7, can be used. Specifically, since a sliding knot is typically tied inthe main suture strand 14′, in minimally invasive rotator cuff repair itis desirable to have two ends of the main suture strand 14′ available.Additionally, as is shown in FIG. 7, the suture arms 22 are attached tothe main suture strand in a manner that allows them to translate alongthe length of the main suture strand 14′.

During the surgical procedure, the surgeon will prepare the soft tissueand bone as described above and as is typical in rotator cuff repairprocedures. An appropriately-sized opening or hole is formed in the boneand the inserter tool 100 is placed either at the mouth of the hole orslightly inside the hole. By depressing the plunger, the surgeon willdeploy the suture anchor elements 24. Then, the inserter tool 100 can beremoved and the main suture strand 14′ passed through soft tissue andtied using techniques known in the art of rotator cuff repair. Dependingon the density of the bone, it may be necessary to remove some amount ofcancellous bone so that the suture anchor elements have adequate spaceto move and come to a planar resting point just underneath the cortex.

ACL Reconstruction

An additional use of the suture anchor assemblies disclosed herein isfor anterior cruciate ligament (ACL) reconstruction. In ACLreconstruction femoral fixation is a common method of reconstructing thedamaged ACL. FIGS. 8A-8C depict a suture anchor assembly 310 in variousstages of use in a femoral fixation procedure.

As part of the surgical technique, an opening in the femur 300 is formedto create a femoral socket 312 using known surgical techniques. Forexample, an appropriately sized femoral socket 312 can be created byfirst drilling a beath pin through a medial surface 314 of the femur atan appropriate entry point and angle to create an opening or cavity inthe femur. The cavity can then be overdrilled to create a passingchannel 316 for the suture anchor assembly 310 that passes through alateral cortex 318 of the femur. Next, the femoral socket 312 ofappropriate length is formed along the passing channel 314 byoverdrilling the socket.

Once the femoral socket 312 is formed, the graft 320 can be attached tothe suture anchor assembly 310 and delivered into the femoral socket312. The graft 320 can be attached to the suture anchor assembly 310 byany means suitable, for example by looping the main suture strand 318around the graft 320. As shown in FIG. 8A, an exemplary suture anchorassembly 310 can have three spherical suture anchor elements 324 and agraft seating suture 326 that is threaded through the passing channel316, for example by passing the graft seating suture 326 through thesuture anchor elements 324. The assembly can further include aninsertion suture 328 that is configured to pass or deliver the sutureanchor elements 324 through the passing channel 316. For example, theinsertion suture 328 can be threaded through or around the distal mostsuture anchor element 324, as shown in FIG. 8A. As shown in FIG. 8B, thesuture anchor assembly 310 can employ a suture management system, thatis, the suture arms 322 can be wrapped around the suture anchor elements324 in a manner that will aid in keeping linear alignment duringdelivery of the suture anchor assembly 310 and that will unravel andexpand when the suture anchor assembly is in a deployed configuration.

As shown in FIG. 8C, once the graft 320 is sufficiently seated in thefemoral socket 312, the graft seating suture 326 can be removed bypulling one end of the graft seating suture 326. The insertion suture328 can then be pulled in a proximal direction (an upward direction inFIG. 8C), so as to advance the suture anchor elements through thepassing channel 316. Once the distal most suture anchor element 324 haspassed through the passing channel 316, the insertion suture can beremoved by pulling one end of the insertion suture 328. In this deployedconfiguration, the suture anchor elements 324 are free to self-assembleinto the coplanar arrangement against the lateral cortex 330 as shown inFIG. 8C.

A person skilled in the art will appreciate that the present disclosurecan have application in any application requiring the fixation of agraft or tissue to bone. For example, the subject matter of thisdisclosure can be used in fixation of the proximal biceps tendon to thehumeral shaft in the sub-pectoral location.

The suture anchor assemblies and inserter tools described herein can beincluded in surgical kits. For example, a surgical kit for repairingtendon or ligament can include a suture anchor assembly, such as thatdepicted in FIGS. 1-4 and 7. That is, the suture anchor assembly caninclude a main suture strand, a plurality of suture arms, each having atleast a first end attached to the main suture strand, and a plurality ofsuture anchor elements, each connected to one of the suture arms,wherein the suture anchor assembly has a delivery configuration in whicheach suture element is substantially aligned along a central axis andable to pass through an opening in bone and a deployed configuration inwhich the suture anchor elements are oriented in a coplanar mannersubstantially parallel to a bone surface and unable to pass through theopening in bone. The surgical kit can further include an inserter toolsuch as that described in FIG. 6. The inserter tool can be configured toselectively maintain the suture anchor assembly in the deliveryconfiguration until deployment. Further, the surgical kit can have aninserter tool with a suture anchor assembly preloaded into the insertertool. The surgical kit can include additional items, such as a pluralityof suture anchor assemblies, additional suture lengths, tissuepreparation tools such as a beath pin, and any other element that istypically used in suture anchor applications.

A person skilled in the art will appreciate that the present inventionhas application in conventional minimally-invasive and open surgicalinstrumentation as well application in robotic-assisted surgery.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A surgical repair method, comprising: forming acavity within bone, the cavity having a cavity diameter; delivering intothe cavity a self-assembling suture anchor assembly in a deliveryconfiguration, the suture anchor assembly having a main suture strand,and a plurality of suture elements each connected to the main suturestrand by a suture arm; deploying the suture anchor assembly bytensioning the main suture strand such that the suture elements arerearranged into a deployed configuration in which the suture anchorelements are oriented in a coplanar manner substantially parallel to thebone surface and unable to pass through the cavity; and securing a graftor soft tissue connected to the suture anchor assembly to bone.
 2. Themethod of claim 1, wherein during the delivery step the suture anchorelements are disposed within an inserter tool and the inserter tool isdisposed through at least a portion of the cavity.
 3. The method ofclaim 1, wherein the graft or soft tissue is attached to the main suturestrand.
 4. The method of claim 1, wherein each suture arm is of asubstantially equal length.
 5. The method of claim 1, wherein eachsuture anchor element is spaced substantially the same distance from adistal end of the main suture stand.
 6. The method of claim 1, whereineach suture arm is attached to the main suture strand at varyinglocations.
 7. The method of claim 1, wherein each suture anchor elementhas a shape that is one of substantially conical and substantiallyspherical.
 8. The method of claim 7, wherein the at least one sutureanchor element has an opening formed therein, the opening beingconfigured to receive the respective one of the suture arms and beingconfigured to be closeable so that the suture anchor element can besecured to the respective one of the suture arms.
 9. The method of claim1, wherein each suture anchor element has a bore extending therethrough,the bore sized and configured to accept respective one of the suturearms in a clearance fit.
 10. The method of claim 1, wherein each sutureanchor element has one or more surface features formed thereon, the oneor more surface features configured to enable joinder of adjacent sutureanchor elements to one another.
 11. The method of claim 1, wherein eachsuture anchor element has at least one invagination surface feature. 12.The method of claim 1, wherein the suture anchor elements are formed ofa material selected from the group consisting of bone, metal, polymers,and ceramics.
 13. The method of claim 1, wherein the suture anchorelements are formed of an osteoconductive material or a bioresorbablematerial.
 14. The method of claim 1, further comprising a graft materialaffixed to the main suture strand.
 15. The method of claim 1, whereinthe suture anchor assembly comprises three suture arms and three sutureanchor elements.
 16. The method of claim 1, wherein each suture anchorelement has at least one groove surface feature thereon configured toreceive the second terminal end of the respective one of the suture armsand secure the respective one of the suture arms to the respectivesuture anchor element.
 17. The method of claim 1, wherein each sutureanchor element is fixedly connected to only the second terminal end ofthe respective one of the suture arms.
 18. A surgical repair method,comprising: forming a cavity within bone; inserting distally into thecavity a self-assembling suture anchor assembly in a first position, thesuture anchor assembly having a main suture strand, a plurality ofsecondary suture strands, and a plurality of suture anchor elements,each secondary suture strand having first and second terminal ends, thefirst terminal end of each secondary suture strand being directlyattached to the main suture strand, the second terminal end of eachsecondary suture strand being directly attached to a corresponding oneof the plurality of suture anchor elements; and transitioning the sutureanchor assembly to a second position by retracting proximally the mainsuture strand to prevent passage of the plurality of suture anchorelements proximally out of the cavity.
 19. The method of claim 18,inserting the suture anchor assembly further comprises inserting aninserter tool having a hollow tubular member configured to house thesuture anchor assembly and a plunger configured to selectively deploythe suture anchor assembly.
 20. The method of claim 18, furthercomprising securing a graft or soft tissue connected to the sutureanchor assembly to bone when the suture anchor assembly is in the secondposition.